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Emotion Study -- A Neurofeedback Approach

21. januar 2020 opdateret af: University of Florida

Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach

This study will determine whether brain activity can be modified and improves performance on a task by showing participants live 'video feed' of their brains on advanced imaging technology. The study is particularly interested in brain regions that have been shown to be relevant for emotions, specifically the anterior insula and the medial prefrontal cortex. Advanced technology will map the brain using magnetic pulses with a real-time functional Magnetic Resonance Imaging (rt-fMRI) machine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Overview: All participants of both age groups will be randomly divided (like tossing a coin) into two groups:

  • One group will have training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text
  • The other group will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text

Further, each of these two groups will be divided into two sub-groups that are different with respect to the training procedure that is used:

* Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training, that has not been associated with any known side effects or safety risks

Number of Study Visits:

This study has the following parts: A pre-training visit, six training visits, and a post-training visit.

With a few exceptions as explained below, the procedures during pre-training, training, and post-training visits are identical.

  • At the beginning of the first visit, the investigator will tell the participant about the study and what is involved and will ask them to sign a consent form. The participant may ask as many questions as they would like before deciding about study participation.
  • For each of the visits, the investigator will review questions with the participant about their health to ensure their eligibility to undergo fMRI on the day of testing.
  • Also for each visit, the investigator will ask the participant to respond to a short questionnaire related to their current mood.
  • In the pre-training and the post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts.
  • For each of the participant's visits, they will spend 50-60 minutes either in the MRI scanner, while viewing pictures and text on a screen. During this time, pictures of the participant's brain at work and at rest will be acquired. In the training visits only, the participant will learn to increase blood flow in certain brain regions with the help of information presented to them on the screen.
  • For each of the participant's visits, they will be asked to respond to a short questionnaire related to their current mood.
  • In the pre-training/post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts as well as their personality. The participant will also perform brief tests related to the thinking process.
  • At the end of each visit, the participant will complete a questionnaire about how they approached the study tasks and whether they experienced any discomfort in the MRI scanner or while wearing the fNIRS system.
  • Upon study completion, the investigator will tell the participant about the general goals of the study and answer any questions that they may have.

The procedure can be stopped at any time.

The study will conclude with debriefing and reimbursement.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32611-2250
        • University of Florida

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Between the ages of 18-30 years or 63-90 years
  • Right-handed
  • Native English speaker

Exclusion Criteria:

  • Pregnant or possibly pregnant
  • Claustrophobia
  • Large pieces of metal in the body, particularly in the face and neck.
  • Piercings or metal implants that cannot be removed from the body
  • Surgery on the brain or any prior serious brain damage or disease
  • Dementia or severe cognitive disorders

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Anterior insula cortex activation
Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text.
Adfærdsmæssigt: Brain activity training - anterior insula
training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
Aktiv komparator: Primary auditory cortex activation
Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text.
Adfærdsmæssigt: Brain activity training - medial prefrontal cortex
training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Increased activation of anterior insula from pre-training to post-training
Tidsramme: Pre-training session (baseline visit); post-training session (approximately one week later)
Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
Pre-training session (baseline visit); post-training session (approximately one week later)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
Tidsramme: Pre-training (baseline visit); post-training visit (approximately one week later)
Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.
Pre-training (baseline visit); post-training visit (approximately one week later)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Efterforskere

  • Ledende efterforsker: Natalie Ebner, PhD, University of Florida, Department of Psychology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

8. januar 2020

Studieafslutning (Faktiske)

8. januar 2020

Datoer for studieregistrering

Først indsendt

10. juli 2014

Først indsendt, der opfyldte QC-kriterier

17. juli 2014

Først opslået (Skøn)

18. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IRB201300814 closed

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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